The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Traditional Treatment

• Registration Number: NCT04269798
• Lead Sponsor: Umm Al-Qura University

Brief Summary

The aim of this study will be to evaluate the effect of FES on stimulation of the anterior tibial group by using the WalkAide foot drop stimulator on improving walking and balance abilities in children with hemiplegic CP.

Detailed Description

The aim of this study will be to evaluate the effect of FES on improving walking and balance abilities in children with hemiplegic CP. Forty children with hemiplegic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for lower limb, balance and gait training. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to FES by using the WalkAide foot drop stimulator. Patients' evaluation will be carried out before and after training to assess walking ability and balance performance.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study Start: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-17
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Their weight should be less than 40 kg.
• The spasticity degrees of the affected lower limb will range between grades (1, 1+ & 2) according to Modified Ashworth Scale (MAS).

Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.

• They can walk 10 min conditionally without an orthosis.
• Ought to be intellectually skilled and ready to comprehend and take after directions.
• They will have neither serious nor recurring medical complications.
• Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
• No serious hip & knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º .
• Peroneal nerve and the proximal leg muscles ought to be in place.
• They ought to have no significant issues influencing balance other than spasticity.

Exclusion Criteria

• Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
• Children with visual, auditory or perceptual deficits.
• Children with surgical interference for the lower limb.
• Children with seizures or epilepsy.
• Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
• Children with pacemakers or other diseases that are contraindicated by electrical stimulation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Traditional Treatment Arm	Traditional Treatment	Will receive conventional rehabilitation program for the lower limbs, balance and gait training. Two hours of conventional physical therapy program /session - 3 sessions/week/ three successive months.
Functional Electrical Stimulation Group	Traditional Treatment	Will receive 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months.

Primary Outcome Measures

Name	Time	Method
Change from baseline postural stability at 3 months	Baseline and 3 months post-intervention	Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).
Change from baseline spatial and temporal gait analysis at 3 months	Baseline and 3 months post-intervention	Spatial and temporal gait analysis will be evaluated for every child at baseline and 3 months post-intervention using the Noraxon's Myo PRESSURE plate.

Trial Locations

Locations (1)

Maternity and Children Hospital; 🇸🇦 Mecca, Saudi Arabia